MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) d10 - concomitant devices - persona stemmed cemented tibial component size d left catalog #: 42532006701 lot #: 67433814, persona posterior stabilized standard femoral component right size 8 catalog #: 42570606402 lot #: 67006639, persona cemented all poly patella 29mm catalog #: 42540000029 lot #: 67454257 g2: foreign - event occurred in canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported during a right knee arthroplasty that while the surgeon attempted to insert a right-oriented articular surface, the cemented tibial component was identified to have been left-oriented.The box and label were confirmed to be marked and labeled appropriately and the surgical team reviewed the boxes prior to opening, however, the tibial component was not identified to be left-oriented until after it had been implanted.Rather than removing the cemented implant, the surgeon opted to utilize a left-oriented articular surface as well to complete the procedure.The patient will be monitored post-operatively.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.As detailed in the instructions for use, "persona system components are sized by matching the femoral and tibial component sizes, styles, and orientations on the product label to the information on the articular surface component label and/or product compatibility charts included in the package insert and surgical technique manual.Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce the service life of the implant." as incompatible devices were used, the root cause is attributed to off-label usage.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23959939
• Report Number: 3007963827-2026-00008
• Device Sequence Number: 20236792
• Product Code: MBH
• UDI-Device Identifier: 00889024237933
• UDI-Public: (01)00889024237933(17)300528(10)67271430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512600512
• Device Lot Number: 67271430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown